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Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

Primary Purpose

Treatment Satisfaction, Participation Rate, Patient, Quality of Life

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness-based stress reduction (MBSR)
Treatment as usual (TAU)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Satisfaction focused on measuring Autism, Adults, Intervention, MBSR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnose within the autism spectrum according to ICD-10, DSM-IV or DSM-5.
  • Minimum ≥18 years of age.
  • Adequate knowledge of the Swedish language.

Exclusion Criteria:

  • Intellectual disability (IQ≤70).
  • Severe mental illnesses that would hinder participation (e.g. psychosis or acute risk for suicidal behaviors).
  • Drug use in the last three months.
  • Poor mental health as assessed with Montgomary Åsberg Depression Rating Scale (MADRS) in combination with semi-structured interview by a clinical psychologist.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mindfulness-based stress reduction (MBSR)

    Treatment as usual (TAU)

    Arm Description

    The 9 session MBSR program following the manual (Kabat-Zinn, 1982).

    Participants take part in their treatment as usual in outpatient habilitation and other services.

    Outcomes

    Primary Outcome Measures

    Study 1 (feasibility study): Treatment completion.
    Participants attending six or more out of the total nine occasions (eight sessions and one retreat) (≥66%) were considered completers.
    Study 1 (feasibility study): Credibility as measured by the Treatment Credibility Scale (TCS: Borkovec & Nau, 1972).
    Five statements scored on a ten-point Likert scale where higher points indicate higher treatment credibility.
    Study 2 (RCT): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
    14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.

    Secondary Outcome Measures

    Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
    14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.
    Study 1 (feasibility study): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983).
    14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately.
    Study 1 (feasibility study): Satisfaction with life as measured by Satisfaction with life scale (SWLS: Diener et al., 1985).
    Five statements scored on a seven-point Likert-scale (1-7) where higher points indicate more satisfaction with life.
    Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003).
    15 statements and scored on a six-point Likert-scale (1-6), where higher scores indicate elevated mindful awareness.
    Study 1 (feasibility study): Acceptance of the Autism diagnosis, assessed by a modified version of the Acceptance and action questionnaire (Bond et al., 2011) for ASD.
    Seven statements and scored on a seven-point Likert-scale , where higher points indicate less acceptance of the ASD diagnosis.
    Study 2 (RCT): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983).
    14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately.
    Study 2 (RCT): Life satisfaction as measured by Satisfaction With Life Scale (SWLS: Diener et al., 1985).
    Five statements scored on a seven-point (1-7) Likert-scale, where higher points indicate more satisfaction with life.
    Study 2 (RCT): Five Facets Mindfulness Questionnaire
    29 statements scored on a five-point (1-5) Likert-scale (Baer et. al., 2006). Higher points indicate higher mindful awareness.
    Study 2 (RCT): Acceptance of the autism diagnosis, assessed by a modified version of the Acceptance and Action Questionnaire (AAQ: Bond et al., 2011) for ASD.
    Seven statements scored on a seven-point (1-7) Likert-scale, where higher points indicate less acceptance of the ASD diagnosis.

    Full Information

    First Posted
    February 8, 2022
    Last Updated
    February 21, 2022
    Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05244265
    Brief Title
    Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults
    Official Title
    Mindfulness Based Stress Reduction (MBSR) for Intellectually Able Autistic Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Terminated
    Why Stopped
    Covid-19 pandemic hindered the group based intervention
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2021 (Actual)
    Study Completion Date
    September 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Region Stockholm

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This project evaluates mindfulness based stress-reduction (MBSR), adjusted and manualized for intellectually able autistic adults. MBSR is a skills training program based on further development of cognitive behavioral therapy. The program includes eight weekly group training sessions and one full-day retreat, aiming at stress reduction and improved coping in everyday life, as well as improved mental health. The aspiration is to make ASD-adjusted MBSR an intervention that is acceptable and accessible to individuals with autism in open clinical care. This includes considering variability in background factors such as age, comorbidity and other personal qualities and preferences. The aim of the studies is to evaluate (1) the feasibility and (2) effectiveness of MBSR in adults (18 or over) with autism without intellectual disability, in an outpatient clinical habilitation context.
    Detailed Description
    Mindfulness based stress-reduction (MBSR) is a well-known skills training program used worldwide (Kabat-Zinn, 1982), with studies showing positive effects in many different conditions. The MBSR program aims at increased conscious awareness and reduced subjective stress. The intervention includes one physical meeting per week (three hours) over eight weeks' time plus one mindfulness retreat day (six hours). The intervention also incorporates meditations and other suggested tasks for participants to do by themselves in-between the group sessions. The delivery of this particular version of MBSR is adjusted to meet the needs of autistic adults, without the contents of the original MBSR program curriculum being affected. Areas that were adjusted are e.g. group size, physical environment, communication, structure, and homework. To ensure high treatment fidelity; the MBSR teachers had teacher training following the international standard, as well as being experienced clinicians working at the habilitation services centers, with extensive knowledge about the target group. All MBSR teachers received supervision and tutoring from highly experienced certified MBSR instructor, in order to ensure that the original MBSR program was followed as closely as possible. The studies were conducted in a clinical outpatient habilitation health care context and thus constitute an important piece in the development of support for adults with ASD. The program will have an effect on facilitating the planning and implementation of feasible and accessible interventions addressing the complex needs of this target group. This research project consists of two studies; one open feasibility trial and one randomized controlled trial (RCT).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Treatment Satisfaction, Participation Rate, Patient, Quality of Life, Mental Illness, Acceptance Processes, Stress, Psychological
    Keywords
    Autism, Adults, Intervention, MBSR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    First study is an open feasibility study, and the second one is a RCT with two parallel group study arms.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Open feasibility study: no masking. RCT: during the screening, assessment of eligibility and completion of T1 (baseline), the allocation to a specific study arm is masked. After T1, all participants, care provider and investigators know which arm (group or treatment as usual) was allocated.
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness-based stress reduction (MBSR)
    Arm Type
    Experimental
    Arm Description
    The 9 session MBSR program following the manual (Kabat-Zinn, 1982).
    Arm Title
    Treatment as usual (TAU)
    Arm Type
    Active Comparator
    Arm Description
    Participants take part in their treatment as usual in outpatient habilitation and other services.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness-based stress reduction (MBSR)
    Intervention Description
    The 8 week (plus one-day retreat) manualized MBSR program according to the manual (Kabat-Zinn, 1982).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Treatment as usual (TAU)
    Intervention Description
    Different interventions and support in outpatient and other services.
    Primary Outcome Measure Information:
    Title
    Study 1 (feasibility study): Treatment completion.
    Description
    Participants attending six or more out of the total nine occasions (eight sessions and one retreat) (≥66%) were considered completers.
    Time Frame
    Immediately after intervention.
    Title
    Study 1 (feasibility study): Credibility as measured by the Treatment Credibility Scale (TCS: Borkovec & Nau, 1972).
    Description
    Five statements scored on a ten-point Likert scale where higher points indicate higher treatment credibility.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 2 (RCT): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
    Description
    14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.
    Time Frame
    Change from baseline to immediately after the intervention.
    Secondary Outcome Measure Information:
    Title
    Study 1 (feasibility study): Perceived stress as measured by the Perceived stress scale (Cohen et al., 1983).
    Description
    14 statements scored on a five-point Likert-scale (0-4) where higher points indicate higher perceived stress.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 1 (feasibility study): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983).
    Description
    14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 1 (feasibility study): Satisfaction with life as measured by Satisfaction with life scale (SWLS: Diener et al., 1985).
    Description
    Five statements scored on a seven-point Likert-scale (1-7) where higher points indicate more satisfaction with life.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 1 (feasibility study): Mindfulness, assessed by Mindful attention awareness scale (MAAS: Brown & Ryan, 2003).
    Description
    15 statements and scored on a six-point Likert-scale (1-6), where higher scores indicate elevated mindful awareness.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 1 (feasibility study): Acceptance of the Autism diagnosis, assessed by a modified version of the Acceptance and action questionnaire (Bond et al., 2011) for ASD.
    Description
    Seven statements and scored on a seven-point Likert-scale , where higher points indicate less acceptance of the ASD diagnosis.
    Time Frame
    Baseline compared to immediately after intervention.
    Title
    Study 2 (RCT): Symptoms of anxiety and depression as measured by Hospital anxiety and depression scale (HADS: the Swedish Lisspers et al., 1997; Zigmond & Snaith, 1983).
    Description
    14 statements scored on a four-point Likert scale from "not at all" to "very often", where higher points indicate more anxiety and depressive symptoms. In addition, sub-scales anxiety and depression were analyzed separately.
    Time Frame
    Change from baseline to immediately after the intervention.
    Title
    Study 2 (RCT): Life satisfaction as measured by Satisfaction With Life Scale (SWLS: Diener et al., 1985).
    Description
    Five statements scored on a seven-point (1-7) Likert-scale, where higher points indicate more satisfaction with life.
    Time Frame
    Change from baseline to immediately after the intervention.
    Title
    Study 2 (RCT): Five Facets Mindfulness Questionnaire
    Description
    29 statements scored on a five-point (1-5) Likert-scale (Baer et. al., 2006). Higher points indicate higher mindful awareness.
    Time Frame
    Change from baseline to immediately after the intervention.
    Title
    Study 2 (RCT): Acceptance of the autism diagnosis, assessed by a modified version of the Acceptance and Action Questionnaire (AAQ: Bond et al., 2011) for ASD.
    Description
    Seven statements scored on a seven-point (1-7) Likert-scale, where higher points indicate less acceptance of the ASD diagnosis.
    Time Frame
    Change from baseline to immediately after the intervention.
    Other Pre-specified Outcome Measures:
    Title
    Study 1 (feasibility study and RCT): Adverse events and serious adverse events.
    Description
    Events reported by participants that occured during intervention (up to 9 weeks) and may or may not be associated with participation in the intervention.
    Time Frame
    At any timepoint during or immediately after the intervention, i.e. not a measure that was assessed for all participants, but reported by any participant that felt he/she had experienced an adverse event.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnose within the autism spectrum according to ICD-10, DSM-IV or DSM-5. Minimum ≥18 years of age. Adequate knowledge of the Swedish language. Exclusion Criteria: Intellectual disability (IQ≤70). Severe mental illnesses that would hinder participation (e.g. psychosis or acute risk for suicidal behaviors). Drug use in the last three months. Poor mental health as assessed with Montgomary Åsberg Depression Rating Scale (MADRS) in combination with semi-structured interview by a clinical psychologist.

    12. IPD Sharing Statement

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    Mindfulness Based Stress Reduction for Intellectually Able Autistic Adults

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